Acute Radiation-Induced Bladder Injury
Conditions
Interventions
Conventional treatment group:Symptomatic treatment + Chinese herbal medicine simulator
Traditional Chinese Medicine Treatment Group:Symptomatic treatment + Chinese herbal granules
Sponsors
Chongqing University Affiliated Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Confirmed as cervical cancer by cytology or histopathology, with staging at IB3~IVA (FIGO 2018), and undergoing radiotherapy with consistent radiation target area settings; (2) Diagnosed with acute radiation cystitis, with injury severity reaching grades 2~4 according to the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) radiation injury grading criteria; (3) KPS score =80, with an expected survival time exceeding 6 months; (4) Age between 18~70 years (including 18 and 70 years); (5) Agreeing to participate in this study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with IVA stage disease involving the bladder (FIGO 2018); (2) Patients with a clear history of allergy to any drugs used in this study (e.g., herbal components in Bazheng Powder and Bai Tou Decoction, etc.), or a history of severe drug allergy reactions (e.g., anaphylactic shock); (3) Patients with a confirmed diagnosis of interstitial cystitis, chronic pelvic pain syndrome, neurogenic bladder, or other underlying bladder diseases, or patients with moderate to severe urinary symptoms (e.g., NRS score = 4) prior to radiotherapy; (4) Patients who, after laboratory and imaging examinations, have been excluded from having diseases causing bleeding and bladder irritative symptoms, such as cystitis or pyelonephritis, which are non-radiation-induced bladder injuries; (5) Patients with severe organ or systemic diseases (e.g., dysfunction of heart, brain, liver, or kidneys; moderate to severe coagulation disorders; severe systemic infections; severe anemia; other malignant tumors), or with significantly abnormal laboratory test results (meeting any of the following criteria: white blood cell count < 3.0×10^9/L; neutrophil count < 1.5×10^9/L; platelet count < 60×10^9/L; red blood cell count < 2.0×10^12/L; hemoglobin < 80 g/L; ALT, AST, or SCR levels exceeding twice the upper limit of normal; total bilirubin exceeding 1.5 times the upper limit of normal); (6) Patients who have participated in or are currently participating in other clinical trials within the past 3 months, or patients for whom the investigator believes other circumstances would hinder participation in this trial, such as pregnancy, mental abnormalities, drug abuse, or alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expanded Prostate Cancer Index Composite, EPIC;The Portuguese Navy Radiation-induced Cystitis, PNRC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine symptom score;Serum inflammatory factors;Pain NRS Score;European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; | — |
Countries
China
Contacts
Public ContactWu Hang Ke
Chongqing University Affiliated Cancer Hospital
Outcome results
None listed